Surgery, Radiation Therapy, and Combination Chemotherapy in Treating Patients With Recurrent Head and Neck Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as amifostine may prevent the side effects of radiation therapy. Combining more than one drug and combining radiation therapy and surgery with chemotherapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining surgery, radiation therapy, and combination chemotherapy in treating patients who have recurrent head and neck cancer that has been treated previously with radiation therapy.
Head and Neck Cancer
Drug: amifostine trihydrate
Procedure: surgical procedure
Radiation: radiation therapy
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Pilot Study of Combined Modality Therapy for Recurrent Head and Neck Carcinoma|
|Study Start Date:||December 1998|
- Determine the effectiveness and toxic effects of intensive salvage therapy and radiotherapy in previously irradiated patients with recurrent head and neck cancer.
- Determine the feasibility and effectiveness of amifostine at limiting or minimizing side effects of repeat irradiation in these patients.
OUTLINE: Patients undergo surgical resection of gross disease (if not already done) followed by 4-6 weeks of rest. Patients receive radiotherapy over 5 consecutive days on weeks 1, 2, 4, and 5. Intravenous cisplatin is administered on days 1-3 and 29-31. Intravenous amifostine is administered 15-30 minutes prior to radiotherapy and cisplatin therapy. Patients receive fluorouracil IV continuously on days 1-4 and 29-32.
Patients are followed every month for 1 year, every 2 months for 1 year, every 3 months for 1 year, every 4 months for 1 year, then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003777
|United States, Pennsylvania|
|University of Pennsylvania Cancer Center|
|Philadelphia, Pennsylvania, United States, 19104-4283|
|Study Chair:||Mitchell Machtay, MD||Abramson Cancer Center of the University of Pennsylvania|